MAUDE Adverse Event Report: OLEN MEDICAL CORP OLSEN; MONOPOLAR FORCEPS

Model Number	12101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the 12101 has burned two patients.
Additional Manufacturer Narrative
To this point, we have not received any additional information from the customer.We will continue to follow up with the customer.This is the first complaint recorded with 152 sold of all lots.A follow up report will be submitted once we have received additional information.
Additional Manufacturer Narrative
The previous follow up stated that the device was available for evaluation.However, this was incorrectly checked as the device was not available for symmetry|olsen to evaluate.No further actions are required.
Additional Manufacturer Narrative
After multiple attempts, the product was not returned for evaluation and pictures were not provided.The customer was not able to provide a lot number or date of purchase to complete a review of device history records and testing completed prior to shipping.Without any of this information, a true investigation cannot take place.The customer did state, however, that they were using the device at a setting of 100.Per the product ifu, the device should be used at the lowest setting possible to get the desired results.This is an isolted event, and based on the above information, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or information pertinent to the investigation, a follow up report will be submitted.

• Brand Name: OLSEN
• Common Device Name: MONOPOLAR FORCEPS
• Manufacturer (Section D): OLEN MEDICAL CORP; 3230commerce center place; louisville KY 40211
• Manufacturer (Section G): OLSEN MEDICAL CORP; 3230 commerce center place; louisville KY 40211
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 15681905
• Report Number: 3000719969-2022-00003
• Device Sequence Number: 12367620
• Product Code: GEI
• UDI-Device Identifier: 00841785102035
• UDI-Public: 00841785102035
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K130669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12101
• Device Catalogue Number: 12101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 10/03/2022; 10/03/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/14/2022; 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown